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Spots Global Cancer Trial Database for Tomotherapy in Postsurgery Recurrent Carcinoma Cervix

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Trial Identification

Brief Title: Tomotherapy in Postsurgery Recurrent Carcinoma Cervix

Official Title: Phase II Study Evaluating the Role of Tomotherapy- Based Intensity Modulated Radiotherapy and Brachytherapy in Postsurgery Recurrent Carcinoma Cervix

Study ID: NCT01117402

Interventions

Radiotherapy

Study Description

Brief Summary: Radiotherapy is the most appropriate treatment for postoperative recurrent carcinoma cervix. However it is technically difficult to deliver adequate doses of RT due to presence of small intestines in the radiation area; thus disease control rates are poor and complication rates are high with conventional radiotherapy. Use of IMRT and brachytherapy for these cases allows for increasing dose to the tumor while sparing normal structures. It is expected that the use of a combination of IMRT \& brachytherapy will achieve higher disease control rates and decrease the complication rates.

Detailed Description: SPECIFIC OBJECTIVES: 1. To evaluate the efficacy of combination of intensity-modulated radiotherapy (IMRT) and brachytherapy in delivering dose escalated radiotherapy in postoperative residual / recurrent cases of carcinoma cervix, in terms of local control proportion and progression free survival (PFS) 2. To study the late and acute toxicities associated with this treatment. 3. Dosimetric comparison of Tomotherapy and conventional IMRT DESIGN: Prospective, phase II study. STUDY POPULATION: All patients of age \< 65 years diagnosed with postsurgery recurrent squamous cell carcinoma cervix without previous history of radiotherapy. STUDY SIZE: 90 patients METHODOLOGY: Ninety cases of cervical cancer with postsurgery recurrence limited to the pelvis will be screened and taken for study if eligible after taking the informed consent. Patients will receive external radiation therapy using IMRT to pelvis with additional dose of localized radiotherapy boost with brachytherapy to the vault with weekly concurrent chemotherapy. The local recurrence rate and 5 year disease free survival rate of all the patients will be studied. PROJECT PERIOD: Total project period : 5 years Recruitment, Data collection : 4 years Complete analysis of data : 1 year STUDY SITE: Tata memorial centre

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Tata Memorial Centre, Mumbai, Maharashtra, India

Contact Details

Name: Reena Engineer, MD

Affiliation: Tata Memorial Centre

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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